483
Carecam International, Inc.Carecam International, Inc. – FDA 483, Oct 23, 2025
Record Details
An FDA inspection of Carecam International, Inc., a drug repackager in Fairfield, NJ, revealed a significant deviation from written procedures for equipment cleaning and maintenance. Specifically, the firm failed to follow its own SOPs for partial cleaning of a packaging room, leading to the presence of previous batch materials and tablets on the floor. This indicates a lapse in maintaining sanitary conditions for drug product handling.
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ID · 28b395a8-6361-4865-9fad-03d18144e4e3
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